FDA 510(k) clearance for next generation percutaneous vertebral augmentation

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Crosstrees Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Crosstrees PVA Pod System for percutaneous vertebral augmentation. FDA clearance was based on a prospective, single-arm investigational device exemption (IDE) study that enrolled 135 patients in the USA, China, Venezuela and Belgium. 

Patient outcomes for the Crosstrees procedure were compared to a literature control which included vertebroplasty and kyphoplasty outcomes. The IDE study met its primary endpoints of a significant reduction in pain scores and PMMA bone cement extravasation over a follow-up period of 12 months. Additionally, the Crosstrees procedure demonstrated a significant reduction in new fracture rates often found with vertebroplasty and kyphoplasty procedures.

The Pod technology was designed to address the need for improved vertebral fracture repair devices by taking a novel approach to controlling the delivery of PMMA to the site of fracture and subsequently reducing the risk of complications caused by PMMA leakage, such as nerve root compression, pulmonary embolism, and additional adverse events as reported in the published literature.

Additionally, the Pod technology’s novel approach to percutaneous vertebral augmentation has been shown to significantly reduce new vertebral fractures post treatment where literature reported rates range from 23–48%. Devices using the Pod technology feature a polymer material to control the delivery of a specific volume and geometry of PMMA bone cement to the vertebral fracture site. Following PMMA delivery, the construct is opened and removed from the vertebra, leaving only the PMMA filler material behind. The Crosstrees procedure involves steps familiar to physicians currently doing percutaneous vertebral augmentation and does not require an implanted device in the spine.

“The PVA Pod System is now FDA-cleared and CE-marked, making a promising new treatment option available to patients with vertebral compression fracture,” said Robert Scribner, president and CEO of Crosstrees Medical. “We very much appreciate the efforts of our investigators and their research staffs in the successful completion of the IDE clinical study and FDA review process. We believe that the POD technology offers the physician unprecedented control of PMMA delivery in vertebral augmentation and has demonstrated significantly improved procedural outcomes for patients.”

“In my experience with the Crosstrees Pod System, the technology presents an important opportunity to improve PVA procedures,” said Philip S Yuan of the Memorial Orthopaedic Surgical Group in Long Beach, USA. “The surgical procedure offers unprecedented PMMA control which may reduce leakage complications, and the 12-month IDE study outcomes clearly demonstrate superior pain relief and reduced new fracture rates in patients with osteoporotic compression fractures.”

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